FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD
K Number: K984541
·
Decision Jan 14, 1999
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
70
Applicant Total
207
Review Days
24
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Basic Information
- Device Name
- GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD
- K Number
- K984541
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3650
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DePuy Orthopaedics, Inc.
- Date Received
- December 21, 1998
- Decision Date
- January 14, 1999
- Product Code
- KWT
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
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